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IMPORTANCE of Standard Operating Procedure SOP in Clinical Research

Any guesses from where Regulatory Authority of India generates majority of its revenue? It’s hard to believe, but it is actually through penalties. The amounts reaches INR 120 Crores every year, only from penalties. The question that arises in every mind is “Why these companies are playing with the health of people?” “Are they doing it deliberately?” The answer might not be “YES” in most of the cases. But most of the penalties are imposed due to the carelessness, which is a byproduct of 'not following a standard procedure in performing Clinical Research and Clinical Trial'. And a document of Standard Operating Procedures, popularly known as SOPs, can prove to be the most effective tool for following a standardized procedure for conducting clinical trials.

A standard operating procedure (SOP) is a document with detailed instructions and methodology to be followed, in order to maintain uniformity and consistency in results. The International Conference of Harmonization (ICH) defines SOP as, “detailed written instructions to achieve uniformity of the performance of a specific function.”

SOPs answers 4 Ws and H concept ie who, what, when, where and how of the investigator's clinical trial management. In clinical research, it is extremely important to comply with the GCP protocols and procedures for two fold reasons. Firstly, any deviation from actual protocol will lead to an incorrect result. Secondly and most importantly, a human life is at stake. So, an SOP should be prepared with utmost care and then it should be followed religiously. Also, it helps in a great way to follow and apply guidelines of Good Clinical Practices (GCP). Apart from all these, it also clearly define the roles and responsibilities of people involved in conducting clinical trial. Hence, making people accountable.

It is the responsibility of everyone (be it pharmaceutical company, contract research organization (CRO), sponsor, investigator, or any other party) involved in the process of drug development to prepare and follow a good SOP, in order to attain highest level of safety and efficacy of performed clinical trial. Regulatory Authority should make it mandatory for all the parties involved or conducting Clinical Research and Clinical Trials to get their SOPs verified before getting a license to perform their operations or trials. Apart from this, every employee in the organization should be well trained to follow these SOPs. An organization following a standard procedure obviously has a competitive edge over those who are not following the standard operating procedure, SOP.

To summarize, the objectives of an SOP are as follows:

  • Improve and maintain the quality of operations and hence effects the result positively.

  • Standardize the working practices.

  • Ensures quality, consistent and reproducible results.

  • Defines the methodology to be followed.

  • Defines the roles and responsibilities of the individuals and department involved.

  • Ensures compliance to GCP and other regulatory guidelines.

  • Saves times



An effective standard operating procedure, SOP should:


  • Be written in a simple, easy to understand language.

  • Be a comprehensive document.

  • Differentiate between instructions and general information

  • Describe procedure in a familiar way.

  • Contain a descriptive title.

  • Contain an indication of SOPs position among other SOPs.


Click Here for A Specimen Standard Operating Procedure, SOP

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